Senior Director, Global Regulatory Strategy & Registration

Alto Neuroscience; Mountain View (CA); Hybrid; USD 210,000 - 285,000; Full time

Job summary

Alto Neuroscience, Inc. in Mountain View, CA, is seeking a Senior Director of Regulatory Strategy & Registration to lead global regulatory strategy across development programs from IND/CTA through NDA/BLA.

The role interfaces with FDA, EMA, MHRA and other authorities, driving expedited pathways and ensuring timely submissions. You will supervise regulatory submissions, maintain KIVO records, and mentor a cross-functional team, partnering with Clinical, CMC, Biostatistics and Medical Writing to

Qualifications

• Advanced degree in a scientific, medical, or health-related discipline.
• 15+ years of progressive regulatory affairs experience in biotech or pharma.
• Experience leading global regulatory strategy and serving as regulatory lead for development programs.
• Direct experience as regulatory lead on IND/CTA through NDA/BLA/MAA programs preferred.

Responsibilities

• Develop and lead global regulatory strategy for assigned programs from IND/CTA through NDA/BLA.
• Serve as GRL for interactions with FDA, EMA, MHRA and other health authorities.
• Identify and manage expedited program designations (e.g., Breakthrough Therapy, Fast Track, SPA, RMAT, Orphan).
• Oversee planning and quality of regulatory submissions and meetings.
• Provide leadership for regulatory strategy across programs and mentor cross-functional team members.
• Coordinate with Clinical, CMC, Biostatistics, Nonclinical, and Medical Writing to align strategy with timelines.

Skills

Regulatory strategy

Global regulatory lead

Cross-functional leadership

Education

PhD/MD/PharmD/MS in RA

Tools

Veeva

KIVO

Job description

Alto Neuroscience, Inc. in Mountain View, CA, is seeking a Senior Director of Regulatory Strategy & Registration to lead global regulatory strategy across development programs from IND/CTA through NDA/BLA.

The role interfaces with FDA, EMA, MHRA and other authorities, driving expedited pathways and ensuring timely submissions. You will supervise regulatory submissions, maintain KIVO records, and mentor a cross-functional team, partnering with Clinical, CMC, Biostatistics and Medical Writing to